The Danish Childhood Obesity Biobank
Primary Purpose
Obesity, Metabolic Disease, NAFLD, Non-alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A family-centered, multidisciplinary obesity treatment program
Sponsored by
About this trial
This is an interventional health services research trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 2- 100 Years old
- Adipose, BMI > 90 % percentile
Sites / Locations
- The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region ZealandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle counseling
Arm Description
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
Outcomes
Primary Outcome Measures
Weightloss, changes in blood parameters and in fatty liver developement.
Secondary Outcome Measures
Full Information
NCT ID
NCT00928473
First Posted
June 25, 2009
Last Updated
November 9, 2020
Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen, Steno Diabetes Center Copenhagen, Holbaek Sygehus
1. Study Identification
Unique Protocol Identification Number
NCT00928473
Brief Title
The Danish Childhood Obesity Biobank
Official Title
The Danish Childhood Obesity Biobank
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen, Steno Diabetes Center Copenhagen, Holbaek Sygehus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.
Detailed Description
The Danish Childhood Obesity Biobank collects data from two cohorts - an obesity clinic cohort and a population-based cohort, of which the latter functions as a reference group.
The biobank continuously and longitudinally includes clinical data and biological samples from children and adolescents in obesity treatment. The population-based cohort has been recruited in a cross-sectional manner from Danish schools, high schools, and dentistries.
Data included in the biobank include venous blood samples, stool, urine, saliva, anthropometrics, body composition by dual-energy X-ray absorptiometry, magnetic resonance imaging and spectroscopy, and genetic markers among others. The data are stored in a central secured electronic database and biological materials are stored in -80-degree Celsius freezers until analyses.
To date, the Danish Childhood Obesity Biobank have included data from more than 5250 children, adolescents and adults from the obesity clinic cohort and more than 4200 from the population-based cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Disease, NAFLD, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
Intervention Type
Behavioral
Intervention Name(s)
A family-centered, multidisciplinary obesity treatment program
Other Intervention Name(s)
(Holm, J. C. et al. Chronic care treatment of obese children and adolescents. Int. J. Pediatr. Obes. 6, 188-196, 2011).
Intervention Description
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
Primary Outcome Measure Information:
Title
Weightloss, changes in blood parameters and in fatty liver developement.
Time Frame
continuously
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2- 100 Years old
Adipose, BMI > 90 % percentile
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens-Christian Holm, Ph.d., MD
Email
jhom@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Christian Holm, Ph.d., MD
Organizational Affiliation
The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
Official's Role
Study Chair
Facility Information:
Facility Name
The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region Zealand
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens-Christian Holm, Ph.d, MD
Email
jhom@regionsjaelland.dk
12. IPD Sharing Statement
Citations:
PubMed Identifier
35726748
Citation
Johansen MJ, Vonsild Lund MA, Angquist L, Fonvig CE, Holm LA, Chabanova E, Thomsen HS, Hansen T, Holm JC. Possible prediction of obesity-related liver disease in children and adolescents using indices of body composition. Pediatr Obes. 2022 Oct;17(10):e12947. doi: 10.1111/ijpo.12947. Epub 2022 Jun 21.
Results Reference
derived
PubMed Identifier
35514021
Citation
Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Fonvig CE, Lankjaer IOJ, Hansen T, Hansen T, Baker JL, Holm JC. Early detection of childhood overweight and related complications in a Danish population-based cohort aged 2-8 years. Obes Res Clin Pract. 2022 May-Jun;16(3):228-234. doi: 10.1016/j.orcp.2022.04.001. Epub 2022 May 3.
Results Reference
derived
PubMed Identifier
35213713
Citation
Stinson SE, Jonsson AE, de Retana Alzola IF, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Fonvig CE, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Hyperglucagonemia in Pediatric Adiposity Associates With Cardiometabolic Risk Factors but Not Hyperglycemia. J Clin Endocrinol Metab. 2022 May 17;107(6):1569-1576. doi: 10.1210/clinem/dgac108.
Results Reference
derived
PubMed Identifier
33596309
Citation
Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.
Results Reference
derived
PubMed Identifier
32571613
Citation
Lund MAV, Thostrup AH, Frithioff-Bojsoe C, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Hansen T, Holm JC. Low-grade inflammation independently associates with cardiometabolic risk in children with overweight/obesity. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1544-1553. doi: 10.1016/j.numecd.2020.04.024. Epub 2020 May 5.
Results Reference
derived
PubMed Identifier
32464183
Citation
Jors A, Lund MAV, Jespersen T, Hansen T, Poulsen HE, Holm JC. Urinary markers of nucleic acid oxidation increase with age, obesity and insulin resistance in Danish children and adolescents. Free Radic Biol Med. 2020 Aug 1;155:81-86. doi: 10.1016/j.freeradbiomed.2020.05.009. Epub 2020 May 25.
Results Reference
derived
PubMed Identifier
31845423
Citation
Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Baker JL, Hansen T, Holm JC. Leptin, adiponectin, and their ratio as markers of insulin resistance and cardiometabolic risk in childhood obesity. Pediatr Diabetes. 2020 Mar;21(2):194-202. doi: 10.1111/pedi.12964. Epub 2019 Dec 26.
Results Reference
derived
PubMed Identifier
31617910
Citation
Johansen MJ, Gade J, Stender S, Frithioff-Bojsoe C, Lund MAV, Chabanova E, Thomsen HS, Pedersen O, Fonvig CE, Hansen T, Holm JC. The Effect of Overweight and Obesity on Liver Biochemical Markers in Children and Adolescents. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz010. doi: 10.1210/clinem/dgz010.
Results Reference
derived
PubMed Identifier
31504107
Citation
Viitasalo A, Schnurr TM, Pitkanen N, Hollensted M, Nielsen TRH, Pahkala K, Atalay M, Lind MV, Heikkinen S, Frithioff-Bojsoe C, Fonvig CE, Grarup N, Kahonen M, Carrasquilla GD, Larnkjaer A, Pedersen O, Michaelsen KF, Lakka TA, Holm JC, Lehtimaki T, Raitakari O, Hansen T, Kilpelainen TO. Abdominal adiposity and cardiometabolic risk factors in children and adolescents: a Mendelian randomization analysis. Am J Clin Nutr. 2019 Nov 1;110(5):1079-1087. doi: 10.1093/ajcn/nqz187.
Results Reference
derived
PubMed Identifier
30460774
Citation
Hollensted M, Fogh M, Schnurr TM, Kloppenborg JT, Have CT, Ruest Haarmark Nielsen T, Rask J, Asp Vonsild Lund M, Frithioff-Bojsoe C, Ostergaard Johansen M, Vincent Rosenbaum Appel E, Mahendran Y, Grarup N, Kadarmideen HN, Pedersen O, Holm JC, Hansen T. Genetic Susceptibility for Childhood BMI has no Impact on Weight Loss Following Lifestyle Intervention in Danish Children. Obesity (Silver Spring). 2018 Dec;26(12):1915-1922. doi: 10.1002/oby.22308. Erratum In: Obesity (Silver Spring). 2019 May;27(5):866.
Results Reference
derived
PubMed Identifier
28762099
Citation
Fonvig CE, Hamann SA, Nielsen TRH, Johansen MO, Gronbaek HN, Mollerup PM, Holm JC. Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. Qual Life Res. 2017 Dec;26(12):3279-3288. doi: 10.1007/s11136-017-1667-5. Epub 2017 Jul 31.
Results Reference
derived
PubMed Identifier
28454530
Citation
Nielsen TRH, Lausten-Thomsen U, Fonvig CE, Bojsoe C, Pedersen L, Bratholm PS, Hansen T, Pedersen O, Holm JC. Dyslipidemia and reference values for fasting plasma lipid concentrations in Danish/North-European White children and adolescents. BMC Pediatr. 2017 Apr 28;17(1):116. doi: 10.1186/s12887-017-0868-y.
Results Reference
derived
PubMed Identifier
27593452
Citation
Rischel HE, Nielsen LA, Gamborg M, Moller P, Holm JC. Comparison of sensory-specific satiety between normal weight and overweight children. Appetite. 2016 Dec 1;107:486-493. doi: 10.1016/j.appet.2016.08.123. Epub 2016 Sep 1.
Results Reference
derived
PubMed Identifier
27560141
Citation
Trier C, Dahl M, Stjernholm T, Nielsen TR, Bojsoe C, Fonvig CE, Pedersen O, Hansen T, Holm JC. Effects of a Family-Based Childhood Obesity Treatment Program on Parental Weight Status. PLoS One. 2016 Aug 25;11(8):e0161921. doi: 10.1371/journal.pone.0161921. eCollection 2016.
Results Reference
derived
PubMed Identifier
26714769
Citation
Fonvig CE, Chabanova E, Ohrt JD, Nielsen LA, Pedersen O, Hansen T, Thomsen HS, Holm JC. Multidisciplinary care of obese children and adolescents for one year reduces ectopic fat content in liver and skeletal muscle. BMC Pediatr. 2015 Dec 30;15:196. doi: 10.1186/s12887-015-0513-6.
Results Reference
derived
PubMed Identifier
26169157
Citation
Lausten-Thomsen U, Christiansen M, Fonvig CE, Trier C, Pedersen O, Hansen T, Holm JC. Reference values for serum total adiponectin in healthy non-obese children and adolescents. Clin Chim Acta. 2015 Oct 23;450:11-4. doi: 10.1016/j.cca.2015.07.012. Epub 2015 Jul 10.
Results Reference
derived
PubMed Identifier
25589213
Citation
Hvidt KN, Olsen MH, Ibsen H, Holm JC. Weight reduction and aortic stiffness in obese children and adolescents: a 1-year follow-up study. J Hum Hypertens. 2015 Sep;29(9):535-40. doi: 10.1038/jhh.2014.127. Epub 2015 Jan 15.
Results Reference
derived
PubMed Identifier
24733029
Citation
Hvidt KN, Olsen MH, Ibsen H, Holm JC. Effect of changes in BMI and waist circumference on ambulatory blood pressure in obese children and adolescents. J Hypertens. 2014 Jul;32(7):1470-7; discussion 1477. doi: 10.1097/HJH.0000000000000188.
Results Reference
derived
PubMed Identifier
24717420
Citation
Hvidt KN, Olsen MH, Holm JC, Ibsen H. Obese children and adolescents have elevated nighttime blood pressure independent of insulin resistance and arterial stiffness. Am J Hypertens. 2014 Nov;27(11):1408-15. doi: 10.1093/ajh/hpu055. Epub 2014 Apr 9.
Results Reference
derived
PubMed Identifier
24318487
Citation
Lausten-Thomsen U, Nielsen TR, Thagaard IN, Larsen T, Holm JC. Neonatal anthropometrics and body composition in obese children investigated by dual energy X-ray absorptiometry. Eur J Pediatr. 2014 May;173(5):623-7. doi: 10.1007/s00431-013-2226-x. Epub 2013 Dec 7.
Results Reference
derived
PubMed Identifier
22157326
Citation
Holm JC, Gamborg M, Neland M, Ward L, Gammeltoft S, Heitmann BL, Sorensen TI, Ibsen KK. Longitudinal changes in blood pressure during weight loss and regain of weight in obese boys and girls. J Hypertens. 2012 Feb;30(2):368-74. doi: 10.1097/HJH.0b013e32834e4a87.
Results Reference
derived
Learn more about this trial
The Danish Childhood Obesity Biobank
We'll reach out to this number within 24 hrs